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Protopic Ointment (tacrolimus)

Indications

• Atopic Dermatitis (Eczema) Used to treat moderate to severe atopic dermatitis in patients who do not respond adequately to conventional therapies.
• Skin Inflammation Helps reduce inflammation and itching in affected areas.

Dosage and Administration

• Follow your doctor’s prescribed dosage and application schedule strictly.
• Apply a thin layer of the ointment to the affected area twice daily, unless otherwise directed by your doctor.
• Wash your hands before and after applying the ointment, unless your hands are the treated area.
• Use the medication only on the skin; avoid contact with eyes, mouth, and mucous membranes.
• Inform your doctor if there is no improvement in your condition after a few weeks of treatment.
• Do not cover the treated area with bandages or wraps unless directed by your doctor.
• Avoid prolonged exposure to sunlight, tanning beds, or ultraviolet light.
• Do not use ointment on infected skin areas.
• Do not use it if you are allergic to tacrolimus or any other component of the ointment.
• Do not share your medication with others, even if they have similar symptoms.

Mechanism of Action

Tacrolimus is an immunosuppressant that works by inhibiting calcineurin, a protein necessary for activating T-cells. By suppressing T-cell activity, tacrolimus reduces the inflammatory response in the skin, thereby decreasing symptoms of eczema such as redness, itching, and swelling.

Contraindications

• Do not use it if you have a known allergy to tacrolimus or any component of the ointment.
• Avoid if you have a history of skin infections at the application site.
• Not suitable for individuals with weakened immune systems or those taking other immunosuppressive medications.
• Do not use it if you have Netherton’s syndrome or similar skin disorders.

Side Effects

Common Side Effects

• Mild burning or itching at the application site
• Skin redness
• Acne
• Headache
• Flu-like symptoms (fever, chills)

Serious Side Effects

• Severe burning or itching
• Skin infection (redness, swelling, pus)
• Swollen glands
• Signs of an allergic reaction (rash, itching, swelling, severe dizziness, trouble breathing)
• Increased sensitivity to sunlight

Precautions

• Inform your doctor about any other medications you are taking to avoid interactions.
• Disclose your complete medical history, especially of skin infections, immune system disorders, and use of other immunosuppressants.
• Use it with caution if you have a history of skin cancer or pre-cancerous skin conditions.
• Avoid contact with eyes, mouth, and other mucous membranes.
• Regularly monitor your skin condition and report any worsening symptoms to your healthcare provider.
• Use sun protection measures, such as wearing protective clothing and applying sunscreen, while using this medication.

Storage Instructions

• Store at room temperature, between 59°F to 77°F (15°C to 25°C).
• Keep the tube tightly closed when not in use.
• Protect from light and moisture.
• Do not freeze.
• Keep out of reach of children and pets.

References

https://www.accessdata.fda.gov/drugsatfda_docs/label/2011/050777s018lbl.pdf